Impact of chronic urticaria on the quality of life of patients followed up

At a university hospital

Gabriela Andrade Coelho Dias1 Gisele Viana Pires2

Solange Oliveira Rodrigues do Valle2 Sérgio Duarte Dortas Júnior2
Soloni Levy3 Alfeu Tavares França2
Ilaria Baiardini4 Walter Giorgio Canonica4

DOI: http://dx.doi.org/10.1590/abd1806-4841.20165071

Abstract: Background: Chronic urticaria is a debilitating disease that considerably affects health-
related quality of life, and the Chronic Urticaria Quality of Life Questionnaire is the only questionnaire
specifically designed for its evaluation.
Objective: To evaluate the quality of life of patients with chronic urticaria, using the Brazilian
Portuguese version of the Chron-ic Urticaria Quality of Life Questionnaire.
Methods: The Chronic Urticaria Quality of Life Questionnaire was self-administered in 112 chronic
urticaria patients and disease activity was assessed through the Urticaria Activity Score. Clinical and
socio-demographic characteristics of patients were studied, such as: age, sex, etiologic diagnosis of
chronic urticaria, duration of disease and Urticaria Activity Score.
Results: The population studied was composed 85.72% of women with a mean age of 46 years (18-
90), while the median dis-ease duration period was 10 years (3 months-60 years). Regarding the
etiologic diagnosis, 48.22% had chronic spontaneous urticaria; 22.32% associated with inducible
urticaria, 28.57% with chronic autoimmune urticaria, and 23.21% had physical ur-ticaria alone.
Disease activity evaluated using the Urticaria Activity Score was 1.04 ± 1.61 (0-6). The total score for
the Chronic Urticaria Quality of Life Questionnaire was 36 (0-100) and dimension I (sleep/mental
status/eating) had a greater impact on quality of life. The items with the highest mean scores were
nervousness and shame over lesions, while the items with the lowest scores were lip swelling and
limitations on sporting activities.
Conclusions: Chronic urticaria compromises patients’ quality of life, mainly those with more severe
disease or who are diag-nosed with chronic autoimmune urticaria.
Keywords: Angioedema; Quality of Life; Questionnaires; Urticaria
such as work, housing and financial concerns.
Health is but one of these factors. The
INTRODUCTION
expression “health-related quality of life”
Chronic urticaria (CU) is a debilitating
(HRQoL) was thus developed to refer to the
allergic skin disease, which affects 0.5 to 1% of
disease’s impact on and therapy in a patient’s
the population and is characterized by
erythematous, papulous and ichty lesions of a life, according to his/her perception.
fluctuating nature that persist for over six
weeks.1 It is highly complex in relation to its
etiology and treatment is challenging, even for
experts.
Quality of life (QoL) has become an
important subject for society and especially for
health professionals. It can be defined as the
individual satisfaction or happiness with life in
domains that the subject considers important.
Several factors may affect a subject’s well-being,
Hence, it is a subjective evaluation from the
patient regarding the impact of health status on
his/her full ability of living.2
In recent decades, the incorporation of
patients’ perceptions into decision-making over
the handling of diseases has been an es-sential
factor in improving the QoL of health assistance
models. The incapacity of traditional clinical
parameters to express what people feel and think
has led to increased interest in the HRQoL field
from the scientific community.3
CU interferes with subjective well-being
and daily life; some patients` health status is
comparable to that of coronary artery disease and
severe asthma patients. It also causes
inconvenience in family structures,
compromising performance at work, school, and
negatively impacting on leisure activities.4,5

Skin pruritus causes variable discomfort, as
well as lesions, which, depending on their
number and location, may harm an indi-vidual’s
physical appearance and social life.6
Sleep disorders such as insomnia, fatigue
and drowsiness - due to pruritus or side effects
from antihistamines - are frequently observed.
Patients complain of recurrent pain syndromes,
includ-ing tension headaches and fibromyalgia,
while the prevalence of psychiatric disorders,
like depression, hysteria, hypochondria and post-
traumatic stress disorder is high.7-9
The degree to which quality of life is
affected varies accord-ing to the chronic
urticaria’s etiology and severity. When CU is
asso-ciated with delayed pressure urticaria, it
affects quality of life more significantly than
urticaria alone.4
HRQoL evaluation of patients with CU is
essential for a better assessment of disease
progression and treatment response. In 2005,
Baiardini et al. developed and validated a
specific question-naire to evaluate the HRQoL in
CU: the Chronic Urticaria Quality of Life
Questionnaire (CU-Q2oL), which has been
shown to, have satisfactory psychometric
properties.10 The CU-Q2oL, originally written in
Italian, was already successfully validated in
Spanish, German, Polish, Turkish, Brazilian
Portuguese, Korean, Greek and Persian.11-18
This study sought to evaluate the HRQoL
in CU patients followed up at the outpatient
chronic urticaria clinic of Hospital Uni-
versitário Clementino Fraga Filho (HUCFF) –
Universidade Federal do Rio de Janeiro (UFRJ),
who have participated in the transcultural val-
idation process of the Brazilian Portuguese
version of the CU-Q2oL, recently adapted and
validated by our group15.
METHODS
This was a cross-sectional study conducted
in the same patient’s sample evaluated in the
Brazilian Portuguese cross-cul-tural adaptation of
the CU-Q2oL study, published in 201115. The
study population comprised both male and
female patients aged over 18, clinically
diagnosed with chronic urticaria, characterized
by the ocurrence of erythematous, papulous,
pruriginous lesions, for a period of over six
weeks, screened from July 2009 to August 2010
at the HUCFF urticaria outpatient clinic. The
study excluded patients diagnosed with acute
urticaria, contact urticaria, urticarial vasculitis,
angioedema with no urticaria, patients unable to
under-stand study terms and to give written
consent, and patients with associated psychiatric
comorbidities - 156 patients were evaluated and
44 were excluded. The study was approved by
the Hospital Eth-ics Committee, and all patients
provided written informed consent to participate.
The Brazilian version of CU-Q2oL includes 23
items that are divided into three dimensions:
sleep/mental status/eating, pruri-tus/impact in
daily activities, and
limitations/appearance/edema.19 The
questionnaire refers to the preceding two weeks,
and the patients indicate the intensity of each
item separately, on
a 5-point Likert scale, ranging from 1 = “not at
all” to 5 = “very much”. A score is calculated for
each dimension, then a total index is calculated
for all the dimensions. The score ranges from 0
to 100. The higher the score, the worse the
patient’s perception of his/her quality of life is.

Urticaria severity was evaluated using the
score proposed by Zurberbier et al. (2001); and
disease severity was assessed via the UAS –
Urticaria Activity Score. The score evaluates the
number of lesions and pruritus intensity. The
sum of scores obtained by evalu-ating urticaria
and pruritus ranges from 0 to 6, where 0
corresponds to controlled disease, while 6
corresponds to high intensity disease.20
The following clinical and socio-
demographic character-istics of the patients were
studied, such as: age (18-40 years, 41-60 years,
> 60 years), sex, etiologic diagnosis of chronic
urticaria (chronic spontaneous urticaria, chronic
autoimmune urticaria and inducible urticaria),
time to disease progression (< and > 5 years) and
UAS (group 1: scores 0 and 1; group 2: scores 2,
3 and 4; group
3: scores 5 and 6). Moreover, the ANOVA
analysis was used to eval-uate the differences
between the groups.
Statistical analysis was performed through
SPSS 17.0 and Stata 8.0. A descriptive statistical
analysis was used in the clinical and
demographic characterization of the patients
studied, and an analysis of variance (ANOVA)
was applied to compare three or four
independent means - p < 0.05 was considered
statistically significant.
This study and the respective informed
consent form were approved by the Hospital
Ethics Committee.
RESULTS
The population studied consisted of 96
female patients (85.72%) and 16 male patients
(14,28%), with a mean age of 46 years (18-90)
and a mean family income of R$1,828.66. In this
sample, 58.03% of patients were married, 37.5%
had not completed elemen-tary school, and
8.03% had completed higher education, 49.11%
were employed, 27.68% were homemakers, and
13.40% were retired (Table 1).
The mean time to disease progression was
10 years (3 months – 60 years), and the follow-
up time at hospital was 4 years. Regarding the
etiologic diagnosis, 48.21% of patients had
chronic spontaneous urticaria (CSU), 22.32%
associated with physical urti-caria, 28.57% had
chronic autoimmune urticaria (CAU) and
23.21% had inducible urticaria alone.
Furthermore, 59.82% of patients re-quired
continuous treatment with antihistamines (Table
2).
Disease activity evaluated by UAS score
was 1.04 ± 1.61 (0-6). Of the 112 patients
enrolled in the study, 8 (7%) did not answer at
least one question from the CU-Q2oL. The item
with the high-est ratio of blank answers was item
4 (lip swelling). The mean total score for the
questionnaire was 36, while dimension I had the
high-est score; however, the score values were
homogeneous for all three dimensions (Table 3).
The items with the highest mean scores
were 15 (nervous-ness), followed by 18 (shame
over lesions) and 1 (pruritus). The low-est scores
were item 4 (lip swelling) and 22 (limtations on
sporting activity) (Table 4).
Seventy-five percent of the patients were
not doing sporting activities and only 16%
indicated chronic urticaria as the reason for this.
Of the 28 patients who played sports, 42.8%
mentioned that urticaria interfered a little,
somewhat, or too much in sporting activity-
related quality of life. Of the 13 patients who
were not practicing sports due to urticaria, 69%
reported that urticaria affected much or very
much.
ANOVA analysis showed that patients aged
41-60 years were
 5
Student 5 (4.46)
Unemployed 6 (5.35)
Income (standard R$1,828.66 –
deviation – SD) R$2,015.86

Table 2: Sample clinical

patients with autoimmune urticaria were more characteristics
impacted in dimen-
sion III, compared with patients suffering from n=
chronic spontaneous Variable 112
urticaria and inducible urticaria alone. Women
Time to disease 10.6 years (3 months to
were more affected in
progression 60
all dimensions but not in a statistically (variation/SD) years/10.6 years)
significant manner. Patients with higher severity Time of follow-up on 4 years (0 to 25
scores (group 3) experienced a greater impact on the job years/4.4 years)
(variation/SD)
quality of life in the total score, and in Type of urticaria (n/%)
dimensions II and III (Table 5). Chronic spontaneous
urticaria
Alone 29 (25.90)
Table 1: Socio-demographic Associated with
characteristics inducible 25 (22.32)
Variable n = 112 urticaria
Autoimmune urticaria
Sex (n/%)
1 8
Male 6 (14.28) (7.15
9 Alone )
Female 6 (85.72) Associated with
46 years old (18- inducible 24 (21.42)
Age (variation) 90) urticaria
Marital status (n/%) Inducible urticaria
6 alone 26 (23.21)
Married 5 (58.03) Continuous use of
2 drugs (n/%) 67 (59.82)
Single 9 (25.90)
Divorced 7 (6.25)
Widow/widower 11 (9.82)
Scholarship (n/%)
Uncompleted 4
elementary school 2 (37.50)
1
Elementary school 9 (16.97)
3
High school 7 (33.04)
Higher education 9 (8.03)
Post-graduate 5 (4.46)
Occupation (n/%)
5
Employee 5 (49.11)
3
Homemaker 1 (27.68)
Retired 1 (13.40)
 patients and may not measure important factors
concerning them. CU-Q2oL is a valid and
DISCUSSION specific instrument to
CU seriously compromises the HRQoL of
patients due to debilitating and uncomfortable Table 4: Item scores
symptoms that may last for years.5 In addition to
classic symptoms, like pruritus and papules, Mean Score (0-
other factors are more relevant for patients with Item 100)
chronic urticaria,
1 Pruritus 49.0
such as unpredictability of flares, sleep disorders, 2 Wheals 37.5
fatigue, drug-re-lated side effects, and physical 3 Eyes swelling 20.8
appearance. Thus, merely evaluating urticaria 4 Lip swelling 12.6
progress by counting lesions and measuring 5 Work 40.5
pruritus in-tensity is insufficient. A holistic 6 Physical activities 25.1
7 Sleep 41.5
evaluation of the patient is required for a better
8 Free time 29.5
understanding of disease impact. In 2010, the 9 Social relationships 31.2
Global Al-lergy and Asthma European Network 10 Eating 28.2
(GA2LEN) study group rec-ommended 11 Falling asleep 36
evaluating the Patient-Reported Outcomes (PRO) 12 Waking up at night 44.3
13 Tired 43.3
and HRQoL in clinical trials on allergy,
14 Concentration 37.5
recognizing the importance of better knowledge 15 Nervousness 55.0
of subjective evaluation of patients in relation to 16 Bad Mood 39.3
health status factors.21 17 Limits foods 35
Most studies on quality of life concerning Embarrassed by
chronic urticaria have used generic 18 signs 52.8
Embarrassed in
questionnaires or those for dermatological dis- 19 public 36.8
eases, such as the DLQI (Dermatology Life 20 Cosmetics 39.5
Quality Index), which was validated as a useful 21 Limits clothes 37.8
instrument to evaluate the HRQoL of pa-tients 22 Sports 17.5
with chronic urticaria.22 However, the DLQI can Medication side
23 effects 41.8
be used for any dermatological disease, since it
was not developed specifically chronic urticaria

Table 3: CU-Q2oL dimension scores

Dimension Item (0-100) Mean score SD

Total score 36 22
10,11,12,13,14,15,16,
I – Sleep/mental status/eating 17 39.9 24.7
II – Pruritus/impact on daily
activities 1,2,5,6,7,8,9,22 34.4 26.4
III – Edema/limitations/appearance 3,4,18,19,20,21,23 34.8 24.8
 Table 5: Distribution of scores and clinical characteristics
Total score 0- Sleep / mental Pruritus / impact Edema /
100/n status / on limitations /
daily activities (0- appearance (0-
eating (0-100) 100) 100)

Sex
Female 36.30 (96) 40.42 41.63 35.84
Male 36.06 (16) 36.94 33.30 28.88
Age
18-40 y 33.03 (36) 32.50a 35.58 31.53
41-60 y 41.07 (56) 48.32a 37.64 37.50
> 60 y 28.65 (20) 29.75a 23.70 33.40
Type
Spontaneou
s 38.53(54) 40.53 38.79 36.66b
Autoimmun
e 40.47 (32) 46.16 34.81 41.28b
Inducible
alone 27.50 (26) 31.69 26.65 24.31b
Disease
duration
< 5 years 35.66 (47) 39.09 36.04 31.66
> 5 years 36.71 (65) 40.52 33.06 37.15
Groups UAS
1 32.06a (85) 37.34 28.06c 31.29d
2 46.53a (19) 48.16 47.47c 44.37d
3 56.63a (8) 47.75 72.00c 50.00d

a: p=0,001, b: p=0,03, c: p<0,0001, d: p=0,02

concerning them. CU-Q2oL is a valid and
specific instrument to evaluate the HRQoL. It is
easily applied and requires five minutes to be
completed by the patient.10 This study aimed to
evaluate the impact of chronic urticaria on the
quality of life of patients followed up at a
university outclinic, to determine which aspects
of quality of life affected these patients the most.
The population evaluated in this study
showed a high prev-alence of chronic urticaria in
women (85.72%). Epidemiological studies
demonstrate that occurrence is twice as high in
female pa-tients.23 A population investigation
conducted in Germany demon-strated that in a
sample of 4,093 people, 1.8% had CU, of which
70.3% were women, while the sample from the
CU-Q2oL original study included 61.84%.10,24
It is frequently noted that women are more
affected by chronic urticaria and other
autoimmune diseases.
In most studies, the peak age of CU
occurrence is between 20 and 40 years.25 Thus,
patients are mainly affected during their working
life years and are more prone to absenteeism and
decreased productivity because of illness and its
treatment. A Spanish study observed that the
mean age of patients was 35.75±18.9 years and
this study population had a mean age of 46 years
(18–70 years).26
Patients had a high educational level
compared with the overall population, with 45%
having at least completed high school, similarly
to the findings of the original study (51.31%).10
The aver-age income was R$1,828.66, while the
average income of Brazilian families in 2010
was R$1,292.00.27 Many diseases have a
prevalence standard, which is dependent on
socio-economic and educational levels. With
respect to urticaria, there is little data available
on this issue. Several studies were not able to
show a difference in the prev-alence of urticaria
in terms of educational level, occupation,
income, residence location, and ethnic
origin.24,26
The mean time to disease progression was
10.6 years (3 months–60 years). In the Baiardini
et al. study, the time was shorter, around 1 year
and 9 months (SD: 27.32 months).10 Gaig et al.
found
that 50% of CU patients were asymptomatic in
three months, and 80% in 12 months. However,
11% were affected for over five years.28 In most
cases, chronic urticaria typically remits after 1-5
years, though 10-20% of cases may last 5-10
years and some can persist for up to 50 years.
Patients with severe urticaria at diagnosis usual-
ly experience longer durations. In our population,
61% of patients presented the disease for over
five years. The authors believe that the high
frequency of long-lasting cases in these series is
due to the institution being a reference center,
which tends to recruit severe and refractory
cases.
Regarding the etiology of chronic urticaria,
just like in the medical literature, a higher
prevalence of CSU (48.21%) was ob-served,
followed by CAU (28.56%), and physical
urticaria alone (23.21%).1 Nevertheless, when all
patients with inducible urticaria (alone and
associated) were considered, a prevalence of
66.95% was found. In the Spanish study, patients
experienced chronic spon-taneous urticaria in
68% of cases, and physical urticaria in 60%.11
About half of the study population did not have
an etiologic diag-nosis despite having undergone
a complete research protocol with challenge tests
for physical urticaria and an autologous serum
test. Affected patients with chronic spontaneous
urticaria suffer deep frustration because of the
uncertainty about the cause of their dis-ease,
which reduces their quality of life.
The first application of the Brazilian
Portuguese version of CU-Q2oL showed that it is
a useful tool to evaluate the disease more
specifically.
The dimension score was not elevated,
ranging from 34.4 to 39.9 on a scale of 0 to 100.
This is because the study population was very
heterogeneous, encompassing patients with
different types of urticaria at various stages of
disease progression. The mean UAS score was
low (1.04 ± 1.61 [0-6]), as 66 patients (58%)
were asymp-tomatic on evaluation day.
Dimension I (sleep/mental state/eating)
revealed a greater
 In relation to age, patients aged between 41
and 60 years had a higher impact in dimension I.
the disease entails sleep disorders, causing This age group includes adults at the peak of
significant damage to mental health, as well as their professional lives, and disturbances in sleep
chronic fatigue, loss of professional pro-ductivity and mental state limit their working lives.
and commitment to their personal and social Variance analysis of CU-Q2oL results
lives. Previ-ous studies have reported that showed that patients with autoimmune urticaria
chronic urticaria has a significant im-pact on (CAU) had the worst quality of life in dimension
quality of life, especially as regards sleep and III (edema, appearance, and limitations). Several
energy, which is consistent with our studies evaluating disease severity have
results.4,29,30 concluded that patients with positive autologous
Question 15, “nervousness”, had the serum skin tests were more affected than those
highest score (55). This finding confirms the with negative tests.23 A multicenter study
high impact of chronic urticaria on the patients’ published in 2009 revealed
mental health. Pasaoglu et al. demonstrated that
patients with chronic spontaneous urticaria had a
higher prevalence of de-pression, hysteria,
hypochondria, and conflicts with their social en-
vironment.8
The questions “embarrassed by signs” and
“pruritus” also revealed a great impact on quality
of life, as the first question assess-es patients
feelings and the second, the main and most
troublesome symptom of this disease, which
interferes with daily activities and mental health.
The question on “lip swelling” had the
lowest score, like in the Spanish study.11
Sporting activities were not regarded as rele-vant
by the patients either, probably because 75% of
the patients in-volved in this study were not
practicing sports and urticaria was the reason for
only 13% of them. The precursor O´Donnel
study showed that 45% of CU patients reported
limitations for running.4
Regarding gender, women were expected
to be more affect-ed than men.12,31 Women
likely have more sensitive skin and mental
awareness toward the symptoms of hives and are
more influenced by changes in appearance. In
fact, a greater impact was found in all
dimensions for women, though there was no
statistical significance.

the highest disease severity and worst quality of
life measured by DLQI in patients with positive
autologous serum skin tests.32
Severity assessment (UAS) demonstrated a
strong correla-tion with the quality of life impact.
Patients with more severe dis-ease showed
greater degree of impairment, especially in
dimension II (itching/impact on daily activities).
In Brazil, there are few studies evaluating
HRQoL in pa-tients with chronic urticaria.
However, it was shown that these patients
underwent an important change in QoL; the most
affected domains were food restrictions,
emotional changes and quality of sleep.33 A
study published in 2011 using DLQI and SF-36,
a generic instrument to evaluate quality of life,
demonstrated greater impair-ment in: women,
patients aged up to 30, those experiencing their
first visit, patients with a high level of education,
those who had the disease for up to 1 year, and
angioedema patients.31 In another Brazilian
study published in 2011, the patients had a mean
score of 13.5 in the DLQI (0-30), the presence of
angioedema was associat-ed with higher scores
(14.3; p < 0.01); women were more limited with
respect to clothing and men with respect to work
and study (p < 0.05).34 In these studies, the
presence of angioedema and be-ing female were
associated with a worse quality of life. This
study highlights a tendency toward a worse
quality of life in women. The difference between
patients with and without angioedema was not
assessed. There is a need for further studies to
define the predictive factors that affect quality of
life in the Brazilian population.
CONCLUSION
Chronic urticaria seriously compromises
the quality of life of patients due to its
debilitating symptoms that can last for years. In
this study, a major impairment was observed in
patients with the highest severity and in those
diagnosed with autoimmune urticar-ia. An
evaluation of quality of life is fundamental to
better assess disease progression and treatment
efficacy, as per recommended by the GA2LEN.
In the future, the Brazilian Portuguese version of
the CU-Q2oL may enable multicenter studies to
be performed, in addi-tion to promoting an
overall understanding of the impact of chronic
urticaria.q